FDA 510(k)

aPROMISE X

K-Number: K220590 · 2022-04-29

Decision Date2022-04-29

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

aPROMISE X is the device name listed in this FDA 510(k) record. The listed applicant is Exini Diagnostics AB. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K220590. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the aPROMISE X?

aPROMISE X is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Exini Diagnostics AB. The 510(k) number is K220590.

When did aPROMISE X receive FDA 510(k) clearance?

aPROMISE X received FDA 510(k) clearance on 2022-04-29, under 510(k) number K220590.

Who is the listed applicant for aPROMISE X?

The FDA 510(k) record lists Exini Diagnostics AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for aPROMISE X?

The FDA product code for aPROMISE X is LLZ.

Other records listing Exini Diagnostics AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211655aPROMISE K191262aBSI

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.